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United States · US · US:35561-252_49fc9324-58cc-2875-e063-6394a90a5363
Sildenafil
Orange BookUNIISPLATC G04BE03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerBostal LLC
CountryUS (United States)
ATC codeG04BE03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc11355612521030 TABLET, FILM COATED in 1 BOTTLE (35561-252-10)
- ndc1135561252141000 TABLET, FILM COATED in 1 BOTTLE (35561-252-14)
Annotations
UNII (FDA Substance ID)
BW9B0ZE037
SILDENAFIL CITRATE
RxCUI 221161
Orange Book
A208494
ABABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "BW9B0ZE037",
"rxcui": "221161",
"inchikey": "DEIYFTQMQPDXOT-UHFFFAOYSA-N",
"display_name": "SILDENAFIL CITRATE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"78c4551c-b922-43c9-9a5a-66377ea07bc2": {
"match": "brand_token",
"title": "SILDENAFIL CITRATE (SILDENAFIL) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]",
"spl_version": "24",
"published_date": "2026-05-29"
}
},
"productid": "35561-252_49fc9324-58cc-2875-e063-6394a90a5363",
"productndc": "35561-252",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "208494",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 25MG BASE",
"product_no": "001",
"approval_date": "Jun 12, 2020"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 50MG BASE",
"product_no": "002",
"approval_date": "Jun 12, 2020"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 100MG BASE",
"product_no": "003",
"approval_date": "Jun 12, 2020"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "SILDENAFIL CITRATE",
"proprietary_name": "Sildenafil",
"active_ingred_unit": "mg/1",
"application_number": "ANDA208494",
"marketing_category": "ANDA",
"nonproprietary_name": "sildenafil",
"start_marketing_date": "20200422",
"active_numerator_strength": "50"
}Related drugs
Other records sharing ATC code G04BE03.
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